The present disclosure is related to the field of miniature- and microfluidics. More specifically, the present disclosure relates to a system comprising an array of fluidic binary switches which enables manipulation of liquids and gases within a three-dimensional channel network. The fluidic binary switch array is composed of reusable and disposable elements, where only the disposable element is exposed to process fluids. Further, the disposable element is designed to be easily and quickly replaced without the need for tools, either by a human or by simple linear automation.
Many chemical and biochemical processing applications make use of single-use disposables to simplify production and ensure the quality of the product. Disposables help achieve this by reducing or avoiding the need for steps such as system set-up verification and validation, cleaning, and cleaning validation. Only process liquids and the final product are exposed to the disposable elements. While disposables simplify the procedure of achieving and maintaining quality in the chemical or biochemical process, the disposable components and the systems that interface with the disposable components are challenging to manufacture/assemble without incurring prohibitive cost from complex structures, materials, or manufacturing processes. An example of a single-use disposable in industrial bioprocessing is the GE Healthcare Life Sciences ReadyToProcess WAVE 25 cell culture device. An example of a single-use disposable in radiopharmaceutical preparation is the GE Healthcare FASTlab cassette for synthesis of Positron Emission Tomography (PET) tracers such as Fluorodeoxyglucose (FDG).
In procedures requiring multiple chemical steps, such as Positron Emission Tomography (PET) tracer synthesis, rotary stop-cock valves and tubing pinch valves are used, with rotary stop-cock valves being the most common. Rotary stop-cock valves are found either as individual pieces, or as an integrated serial bank. In the case of integrated serial banks, valve arrays consisting of 25 or more valves connected in series, are manufactured as a single part, to reduce the number of individual parts requiring assembly. The valves provide process fluid control and are one of the critical components in the disposable element. The valves are connected to the other required components, such as pumps, filters, and reactors, via tubing and fittings.
The combination of rotary valves, other essential components such as pumps, filters, and reactors, and tubing, results in the complete disposable. This disposable, together with reagents, is referred to as the disposable kit. These kits have proven to be successful however the use of tubing and the serial connection of valves in banks for use as a single component, has limitations. Assembly of tubing with fittings and other parts is a difficult process to automate, and the applications utilizing the described disposables often do not have the manufacturing volumes to justify investment into the automation of the tubing into the assemblies. This means that the tubing is assembled by hand. The use of serial valve banks to reduce the number of individual parts in the assembly limits the overall flexibility in the routing of fluids, which can lead to undesirable or non-intuitive routing of fluids to avoid cross-contamination. Furthermore, dead-volumes tend to be difficult to reduce due to the limitations of the components and their need to be suitable for assembly by hand. Reduction of dead-volumes is essential in applications that use expensive compounds, where there is a trend to process volumes as small as possible.
Miniature- and micro-fluidics, and integrated manifolds are technologies that reduce or eliminate the use of tubing, however there is a need in the field for robust physical interfaces between components in disposable kits.